Verification of The Cloud DX Vitaliti™ Continuous Vital Sign Monitor (CVSM): Non-invasive Blood Pressure Component

Verification Protocol for The Cloud DX Vitaliti™ Continuous Vital Sign Monitor (CVSM): Non-invasive Blood Pressure Component for Clinical Use and Self Measurement According to the American Safety in Medical Technology and the IEEE

The purpose of this study is the verification of Cloud-DX Vitaliti™ Continuous Automated Non-Invasive Blood Pressure Monitor for Clinical Use and Self Measurement according to standards laid out by IEEE Std 1708 and AAMI-ISO 81060-2.

Study Overview

• Status: Completed
• Conditions: Blood Pressure
• Intervention / Treatment: Device: Vitaliti

Detailed Description

Several automated vital sign measurement systems have been developed recently; however, non-invasive continuous blood pressure monitoring continues to be a major limitation. To circumvent the limitations of current systems of interval hemodynamic measurement and increasing demands on health care providers, a non-invasive automated continuous vital sign monitor that can integrate into hospital early warning systems and warn health care providers of deteriorating vital sign parameters would be of significant value and a major advance for current hospital monitoring systems.

Cloud-DX Vitaliti™ is a new low profile automated vital sign monitor, which includes a continuous non-invasive blood pressure measurement system. Additional parameters are also measured. Paired with companion software from cloud based computing, Vitaliti™ features a user friendly interface, onboard radios for communication with smartphones/tablets/personal computers, and several sensors.

Cloud-DX Vitaliti™ has undergone preliminary testing and is now ready for verification to achieve compliance with AAMI/ISO and IEEE standards of medical grade device. At the Hamilton General Hospital (HGH), Cardiac Surgical Intensive Care Unit (CICU) and Vascular Surgical Step Down Units, arterial catheters are standard of care and performed on most patients for variable periods of post-operative recovery. Within this setting, the IEEE Std 1708 and AAMI-ISO 81060-2 would be fully met. Furthermore, the cardiovascular surgical caseloads at HGH would provide sufficient test subjects to validate VitalitiTM in a timely fashion.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients ≥18 years of age;
2. Patient has undergone major cardiac or vascular surgery and has been admitted post-op to the cardiac surgical intensive care unit (CICU) or vascular surgery step down unit with an arterial line in place

Exclusion Criteria:

1. Patients < 18 years of age;
2. Pregnant;
3. Current arrhythmia
4. Blood pressure outside of test range for phase (refer to table 1)
5. Allergy to device contact adhesive (e.g. ECG leads)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Vitaliti; The subject's blood pressure will be simultaneously determined and recorded using the invasive arterial line blood pressure reading and the test Vitaliti device readings.	Device: Vitaliti; Measurements recorded by the Vitaliti device will be compared to the recordings from the arterial catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Determining the accuracy of non-invasive blood pressure measurement compared to invasive blood pressure. A detailed analysis will be conducted on the invasive blood pressure to verify accuracy as defined in the ISO 81060-2 Standard.	30 minutes

Collaborators and Investigators

• Sponsor: Population Health Research Institute
• Collaborators: Federal Economic Development Agency for Southern Ontario (FedDev Ontario)
• Investigators: Principal Investigator: Michael McGillion, RN, PhD, School of Nursing, Faculty of Health Sciences, McMaster University

Publications and helpful links

General Publications

• McGillion MH, Dvirnik N, Yang S, Belley-Cote E, Lamy A, Whitlock R, Marcucci M, Borges FK, Duceppe E, Ouellette C, Bird M, Carroll SL, Conen D, Tarride JE, Harsha P, Scott T, Good A, Gregus K, Sanchez K, Benoit P, Owen J, Harvey V, Peter E, Petch J, Vincent J, Graham M, Devereaux PJ. Continuous Noninvasive Remote Automated Blood Pressure Monitoring With Novel Wearable Technology: A Preliminary Validation Study. JMIR Mhealth Uhealth. 2022 Feb 28;10(2):e24916. doi: 10.2196/24916.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 9, 2018
• Primary Completion (ACTUAL): November 6, 2019
• Study Completion (ACTUAL): November 6, 2019

Study Registration Dates

• First Submitted: March 16, 2018
• First Submitted That Met QC Criteria: April 3, 2018
• First Posted (ACTUAL): April 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Wearable device; Non-invasive blood pressure monitoring; Medical device verification study
• Other Study ID Numbers: STP-VIT-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data which will be collected is only valid for the verification of this particular device.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No